Patient-reported outcomes in core domain sets for rheumatic diseases

Area of Science:

• Rheumatology
• Clinical Trial Methodology
• Patient-Reported Outcomes Research

Background:

• The increasing number of patient-reported outcomes (PROs) in rheumatology necessitates identifying the most critical measures.
• Core outcome sets aim to standardize outcome measurement in clinical trials for rheumatic diseases.

Purpose of the Study:

• To review and summarize the PROs included in established core outcome sets for rheumatic diseases.
• To identify commonly utilized PROs across various rheumatic conditions in clinical trials.

Main Methods:

• Systematic review of literature on core outcome sets in rheumatology.
• Analysis of PRO domains and instruments within defined core outcome sets.

Main Results:

• Pain, physical functioning, and patient global assessment of disease activity are the most frequently included PROs in core outcome sets.
• These three PROs are utilized across a wide spectrum of rheumatic conditions.

Conclusions:

• Pain, physical functioning, and patient global assessment are essential PROs for rheumatology clinical trials.
• Further research is needed to clarify the role of patient global assessment, differentiate health-related quality of life domains, and establish consensus on generic versus disease-specific instruments.